Overview
- 9 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
9
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2026 – 6 Feb 2026 | Human Drugs | 483 | View 483 → |
| 22 Jan 2024 – 2 Feb 2024 | Human Drugs | WL | View 483 → |
| 4 Nov 2019 – 13 Nov 2019 | Medical Devices & Rad Health | 483 | On file |
| 3 Dec 2018 – 14 Dec 2018 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 20 Feb 2018 | Human Drugs | 483 | View 483 → |
| 20 Apr 2017 – 28 Apr 2017 | Human Drugs | 483 | View 483 → |
| 6 Sep 2016 – 16 Sep 2016 | Human Drugs | 483 | View 483 → |
| 18 Sep 2014 – 26 Sep 2014 | Human Drugs | 483 | On file |
| 12 Sep 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Feb 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Patty P Kaewussdangkul, Lisa L Flores, Unnee Ranjan
6 Feb 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Patty P Kaewussdangkul, Lisa L Flores, Unnee Ranjan
6 Feb 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Patty P Kaewussdangkul, Lisa L Flores, Unnee Ranjan
6 Feb 2026
21 CFR 211.165(a)
Testing and release for distribution
Cited by Patty P Kaewussdangkul, Lisa L Flores, Unnee Ranjan
6 Feb 2026
21 CFR 211.167(a)
Sterility/pyrogens - test methods written, followed
Cited by Patty P Kaewussdangkul, Lisa L Flores, Unnee Ranjan
Investigators
FDA investigators tied to this site in the record.
Scott T Ballard2 insp.
Patty P Kaewussdangkul1 insp.
Lisa L Flores1 insp.
Unnee Ranjan1 insp.
Anastasia M Shields1 insp.
Justin A Boyd1 insp.
Eileen A Liu1 insp.
Dipesh K Shah1 insp.
June P Page1 insp.
Thomas J Arista1 insp.
Freddy Ortiz Colon1 insp.
Marie B Buen-Bigornia1 insp.
Jose A Cruz Gonzalez1 insp.
Atul Agrawal1 insp.
Yasamin Ameri1 insp.
Saleem A Akhtar1 insp.
Nebil A Oumer1 insp.
Barbara D Paul1 insp.
Eric M Mueller1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eugia Pharma Specialities Limited's 8 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat